SOURCES SOUGHT
Q -- Evaluation of mature and functional Hepatocyte Organoids derived from induced pluripotent stem cell
- Notice Date
- 7/22/2020 6:54:36 PM
- Notice Type
- Sources Sought
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-NCATS-SB-SS-20-004597
- Response Due
- 7/29/2020 9:00:00 AM
- Archive Date
- 12/31/2020
- Point of Contact
- Debra C. Hawkins, Phone: 3018277751
- E-Mail Address
-
Debra.Hawkins@nih.gov
(Debra.Hawkins@nih.gov)
- Description
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition.� It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract.� Responses will not be considered as proposals or quotes.� No award will be made because of this notice.� The Government will NOT be responsible for any costs incurred by the respondents to this notice.� This notice is strictly for research and information purposes only. Project Requirements.� The Tox21 group of National Center for Advancing Translational Sciences (NCATS), Division of Preclinical Innovation (DPI) requires a service named �Evaluation of mature and functional Hepatocyte Organoids derived from induced pluripotent stem cell� from 3Dnamics Inc. The service will be used to study liver toxicity caused by a group of compounds that identified from Tox21 mitochondrial 10K screening project, which is one of the key projects in the Tox21 program. The purpose of the work requirement is to support the evaluation of chemical effect on the pathophysiology level that are involved in mitochondrial toxicity. This project is one of the cross-partner projects in the Tox21 collaboration between NCATS and NTP/EPA/FDA. The mission of the Tox21 group of NCATS at the National Institutes of Health (NIH) is to develop better toxicity assessment methods to quickly and efficiently test chemicals for their potential disrupt processes in the human body that may lead to negative health effects. ��Mitochondria play a central role in cellular metabolism including heme, fatty acid, and steroid synthesis; metabolic cell signaling; oxidative phosphorylation; Ca2+ homeostasis; and apoptosis. Mitochondrial toxicity is one of major mechanisms of chemicals in organ toxicity, including the heart, nerves, muscles, pancreas, kidneys, and liver. As a participant of Tox21 program, we have screened the Tox21 10k compound library in a cell-based mitochondrial membrane potential (MMP) assay and identified a group of novel compounds that significantly decreased MMP. To further in-depth investigation these chemicals, the iPSC-derived liver organoids will mimic liver development, expressed key functional hallmarks of the liver such as expression of metabolic enzymes cytochrome and sulfotransferases. ��Having an in vitro model that can mimic the physiology and functions of a human liver is immensely invaluable to developing assays for drug metabolism and toxicology, screening for potential antiviral agents, predicting in vivo drug metabolism, and creating cell-based therapies to treat liver diseases. While there are numerous protocols that can differentiate induced pluripotent stem cells (iPSCs) into hepatocytes, they are inconsistent and not amenable to drug testing. These issues are mainly due to our lack of understanding of human liver development, and that most of the protocols were developed using a monolayer culture system that is insufficient to replicate the cell-cell interactions and complex signaling in three dimensional tissues. Liver organoids differentiated from pluripotent stem cells may overcome these issues and provide a more accurate and predictive liver model for drug development. Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the�specific requirements below. Scope of Work.� The contractor shall evaluate mature and functional Hepatocyte Organoids derived from induced pluripotent stem cells using differentiation protocols developed by 3Dnamics, 1812 Ashland Avenue, Baltimore, MD 21205.� Specifically, the contractor shall: (1) upon receipt, inspect vials and make certain cells arrive in proper conditions and will take necessary steps for proper storage of cells until project start date; (2) expand wildtype iPSC lines into liver organoids; (3) differentiate iPSC into liver organoids; (4) characterize and quality assessment of liver organoids; (5) generate multiple batches of liver organoids (1000+) for additional assays and drug screening at different time points and stages; and (6) ship the hepatocyte organoids to the government via FedEx overnight shipping on dry ice or in person. Government Responsibilities.� The Government will; (1) provide to the contractor the frozen iPSC lines and some of the reagents; (2) prepare and package the cells; and (3) notify the contractor when cells are shipped. Project Timeline.� Two (2) Weeks (from state date):� Expansion of wildtype iPSC lines. Four (4) to Six (6) Weeks: Differentiation of iPSC into liver organoids Four (4) to Six (6) Weeks: Characterization and quality assessment of liver organoids Six (6) to Thirty (30) Weeks: Generation multiple batches of liver organoids (1000+) for additional assays and drug screening at different time points and stages. Deliverables: 1. Characterization (immunostaining, functional analysis, etc.) of organoids at different stages (7-, 14-, and 21-day or longer if necessary); and 2. Multiple batches of hepatocyte organoids at different time points and/or stages of maturation. Reporting Requirements. �1. Complete data package including spreadsheet of raw data (viability counts, immunocytochemistry quantification, etc.); and 2. Complete data work-up and full report for four patient lines and two WTs. Data Rights.� All data used and analyzed is sole property of the government. Contractor has no right to any analyzed iPSCs lines provided by Tox21 group and must keep them confidential. Anticipated period of performance / delivery date:� The Government anticipates a period of performance of 12-months. INFORMATION SUBMISSION INSTRUCTIONS:� Capability statement /information sought.� The government is interested in soliciting capability statements from all qualified Offerors demonstrating their ability to perform this effort. At a minimum, respondents to this notice must provide, as part of their response, a capability statement to include the following:� (1) information regarding the respondents� (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of a similar nature; (d) corporate experience and management capability; and, (e) examples of prior completed Government contracts, references, and other related information;� (2) respondents� DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc.) pursuant to the applicable NAICS code;� and, (3) any other information that may be helpful in developing or finalizing the acquisition requirement. Other important considerations: The response may cite any other information that is necessary for potential respondents to understand the nature of the potential requirement or proposed acquisition. Respondents should provide responses accordingly: (1) submit information electronically.� No telephone or facsimile responses will be accepted; (2) format capability statements using Microsoft Word or Adobe PDF including attachments, resumes, charts, etc. �Use single space, 12 font minimum and 8 � x 11 size paper; (3) organize material in such a manner that clearly identifies and address capability requirements and provide an executive summary; (4) capability statement should not exceed ten (10) pages including references; (5) DUNS number; (6) respondents must send via email to Debra C. Hawkins Contractor, Acquisition Policy Analyst II, at debra.hawkins@nih.gov; (7) responses are due July 29, 2020, 12:00 Noon Eastern Time; and (8) include respondents� technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. Disclaimer and Important Notes:� This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization�s qualifications to provide the product or perform the services specified herein.� Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/c022bf0d54c945a0afae871d13c68f06/view)
- Place of Performance
- Address: USA
- Country: USA
- Country: USA
- Record
- SN05730075-F 20200724/200722230148 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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